BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB LS 1.3MM TPRD PN KIT

    MDR report key: 5364318 · Received January 13, 2016

    Report

    Report Number
    0001825034-2016-00149
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 28, 2015
    Report Date
    December 31, 2015
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, ¿BENDING, FRACTURE, LOOSENING, RUBBING AND MIGRATION OF THE DEVICES CAN OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA OR LOAD BEARING.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FOOT PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, A PIN CRUMBLED WHEN INSERTED INTO THE PATIENT'S FOOT. ALL PIECES WERE RETRIEVED FROM THE PATIENT, A K-WIRE WAS USED, AND AN ADDITIONAL HOLE WAS CREATED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22904 ORTHOSORB LS 1.3MM TPRD PN KIT PIN, FIXATION OVZ BIOMET TRAUMA N/A 768100

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R